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Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

article  14

CELEX:  32021R2282

Updates of joint clinical assessments
1. The Coordination Group shall carry out updates of joint clinical assessments where the initial joint clinical assessment report specified the need for an update when additional evidence for further assessment becomes available.
2. The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members and new clinical evidence is available. When preparing the annual work programme the Coordination Group may review and decide on the need for updates of joint clinical assessments.
3. Updates shall be carried out in accordance with the same requirements set out pursuant to this Regulation for a joint clinical assessment and the procedural rules established pursuant to Article 15(1).
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

article  14

CELEX:  32021R2282

4. Without prejudice to paragraphs 1 and 2, Member States may carry out national updates of assessments on health technologies that have been subject to a joint clinical assessment. The members of the Coordination Group shall inform the Coordination Group before such updates are initiated. Where the need for the update concerns more than one Member State, the members concerned may request the Coordination Group to conduct a joint update pursuant to paragraph 2.
5. Once concluded, national updates shall be shared with the members of the Coordination Group via the IT platform referred to in Article 30.